FDA 510(k)

Annalise Enterprise CTB Triage Trauma

K番号: K223240 · 2023-04-03

決定日2023-04-03

製品コードQAS

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

Annalise Enterprise CTB Triage Trauma is the device name listed in this FDA 510(k) record. The listed applicant is Annalise-Ai Pty , Ltd.. It received FDA 510(k) clearance on 2023-04-03 under 510(k) number K223240. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Annalise Enterprise CTB Triage Trauma?

Annalise Enterprise CTB Triage Trauma is a medical device that received FDA 510(k) clearance on 2023-04-03. The listed applicant is Annalise-Ai Pty , Ltd.. The 510(k) number is K223240.

When did Annalise Enterprise CTB Triage Trauma receive FDA 510(k) clearance?

Annalise Enterprise CTB Triage Trauma received FDA 510(k) clearance on 2023-04-03, under 510(k) number K223240.

Who is the listed applicant for Annalise Enterprise CTB Triage Trauma?

The FDA 510(k) record lists Annalise-Ai Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Annalise Enterprise CTB Triage Trauma?

The FDA product code for Annalise Enterprise CTB Triage Trauma is QAS.

申請者としてAnnalise-Ai Pty , Ltd.を記載するその他の記録

K231767Annalise Enterprise CTB Triage Trauma K231384Annalise Enterprise CTB Triage Trauma K231094Annalise Enterprise CTB Triage-OH K222179Annalise Enterprise CXR Triage 外傷 K222268Annalise Enterprise CXR Triage 外傷

公式ソース

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